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Leakage Current Testing 102

• Brief review of the Leakage Current Test

• General Patient Leakage Current

• Patient Auxiliary Leakage Current

• Mains on Applied Park Leakage Testing

• Medical Device Leakage Testing Considerations

Webinar Notes

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Touch Current

Leakage Current

IEC 60601-1

• IEC 60601-1 3rd Edition and the leakage current tests•Tests called out for in the standard

Learning Objectives

• Touch Current• Patient Leakage• Patient Auxiliary Leakage• Mains on Applied Part Leakage.

• Description• Network and MD

TestingExamples

• IEC 60601-1 discussion and reference diagrams•Leakage testing video examples

1 – IEC 60990 2nd edition: Methods of Measurement of Touch Current and Protective Conductor Current2 – IEC 60601-1 3rd edition: Medical Electrical Equipment

Leakage Current Types

Patient Leakage Current

Patient Auxiliary Current

Current flowing in the patient in normal use between any patient connection and all other patient connections (and not intended to produce a physiological effect)2.

• Electric current through a human body when it touches one or more accessible parts of an installation or surface of electrical equipment1

• Also called Enclosure Leakage Current.

• Current flowing from the patient connections via the patient to earth • Current originating from the unintended appearance of a voltage from an external

source on the patient and flowing from the patient via the patient connections of an F-Type applied part to earth.

Mains on Applied

Part

Application of mains voltage on an applied part or patient lead.

Leakage Current Types

Patient Leads

F-Type: APPLIED PART in which the PATIENT CONNECTIONS are isolated from other parts of the ME EQUIPMENT

Type BF: F-TYPE APPLIED PART provide a higher degree of protection

against electric shock than that provided by TYPE B APPLIED PARTS

Type CF: F-TYPE APPLIED PART provide a highest degree of protection against electric shock than that

provided by TYPE BF APPLIED PARTS

B Type: APPLIED PART that provides protection against

electric shock

Patient Lead Types

IEC 60601-1 3rd edition: Medical Electrical Equipment

THE MAIN QUESTION TO ASKWhat is the severity of electric current someone would be exposed to if they were to touch the DUT under such conditions?

Normal and Single Fault Conditions

Measurements taken under normal conditions.Measurements also taken under single fault conditions to simulate worst case scenarios

Body Impedance

MD is designed to simulate the impedance of the human body under various conditions.

MD

Leakage current is measured through a human body impedance network, also known as a Measuring Device (MD)

How Is It Measured?

Medical Devices IT Equipment

Electric Spas

How Is It Measured?

MD will vary by product standard. Most MDs are derived from IEC 60990-1

Poll QuestionQuestion Goes Here

A. Answer Choice AB. Answer Choice BC. Answer Choice C D. Answer Choice D

IEC 60601-1 Medical Equipment

Patient Leakage Current

Patient Leakage Current

60601-1 – Figure 14

Touch Current

60601-1 – Figure 15

Touch Current

Video Demonstration

Patient Auxiliary Current

Mains on Applied Part

Poll QuestionQuestion Goes Here

A. Answer Choice AB. Answer Choice BC. Answer Choice C D. Answer Choice D

Leakage current

External voltage on SIOFigure 17

External voltage on metal accessible part

that is not PEFigure 18

Mains Voltage on Applied Part

Figure 16

Additional Tests and Considerations

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